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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting stent (Boston Scientific), in patients with diabetes.
We plan to compare endothelial coverage and neointimal proliferation using OCT and compare this data to published results from conventional stents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resolute Integrity Stent | Active Comparator | Patients will be randomised in a 1:1 ratio to receive two different types of DES |
|
| Promus Stent | Active Comparator | Patients will be randomised in a 1:1 ratio to receive two different types of DES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial stent coverage | Endothelial coverage expressed as % of struts without coverage as measured by OCT | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal hyperplasia | Neointimal hyperplasia (mm2) as measured by OCT | 6 month |
| MACE | death, heart failure, myocardial infarction, stroke, need for repeat revascularisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mathur, FRCP FESC | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Chest Hospital, Barts Health NHS Trust | London | E2 9JX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29632674 | Derived | Hamshere S, Byrne A, Choudhury T, Gallagher SM, Rathod KS, Lungley J, Knight CJ, Kapur A, Jones DA, Mathur A. Randomised trial of the comparison of drug-eluting stents in patients with diabetes: OCT DES trial. Open Heart. 2018 Apr 5;5(1):e000705. doi: 10.1136/openhrt-2017-000705. eCollection 2018. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| 6 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |